May 30, 2022
Buchanan Ingersoll and Rooney PC
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The FDA has become increasingly concerned about products containing cannabidiol (CBD) and / or delta-8 tetrahydrocannabinol (delta-8), claiming that these products are potentially unsafe, and are alleging violations of the Federal Food Act. drugs and cosmetics (FFDCA). and “are packaged and labeled in a way that children can enjoy.” These concerns, along with recent reports related to delta-8 and CBD products, led to the issuance of five additional warning letters.
In these warning letters, the FDA stated that certain products containing CBD and / or delta-8 were new unapproved drugs sold in violation of section 505 (a), § 301 (d) of the FFDCA. [21 U.S.C. 355(a),
331(d)] and were incorrectly marked under section 502 (f) (1) of the FDCA [ 21 U.S.C.
352(f)(1)] as companies market it as non-approved treatments for various medical conditions or for other therapeutic uses. Referring to the addition of CBD and delta-8 to foods such as jelly beans, chocolate, and candy, the FDA determined that certain foods were adulterated under FFDCA § 402 (a) (2) (C) (i)
[ 21 U.S.C. 342(a)(2)(C)(i)], because delta-8 is considered an unsafe food additive. In addition, for those companies that also sold delta-8-containing animal products, the FDA stated that these products were not approved and were not new animal medications under FFDCA § 512 (a) [21 U.S.C. § 360b(a)]and are adulterated under FFDCA § 501 (a) (5) [21 U.S.C. 351(a)(5)].
In other words, these warning letters were perfected in marketed products containing CBD or delta-8 that claim to treat medical conditions in humans and animals, promoting products such as dietary supplements and / or adding CBD or delta-8 to human food. and animals as an unapproved food additive. Specific claims made by manufacturers that received these warning letters include:
- Blog post: “Delta-8 THC can be used to suppress the immune response in your body. If a patient has autoimmune diseases, Delta-8 THC will offer some relief and support. Some of these diseases include lupus, HIV / AIDS and multiple sclerosis “.
- Blog post: “Fighting cancer … Δ8 may also have cancer properties … [t]The researchers treated mice with cancer for 20 consecutive days with a combination of isomer and cannabinol. The result? Tumors reduced in size “.
- Twitter Post: “Benefits of CBD Oil … Relieves Pain and Inflammation … Helps Fight Cancer … Relieves Nausea … Treats Seizures … Reduces Diabetes Risk .. Anxiety … Depression … Panic Disorders … OCD … PTSD … Neurological Disorders … “
- Facebook Page: “500mg: CBD & Menthol Pain Cream … bioMDplus 500mg CBD Pain Cream is a new topical pain relief cream made to soothe sore muscles and relieve chronic joint pain. Derived from our Powerful hemp oil with mint oil infusion, eucalyptus oil, menthol and our terpene blend, this cream allows for a unique and STRONG combination of natural ingredients and CBD to help with a POWERFUL relief. new topical pain cream to FIGHT muscle aches and sore joints! “
- Facebook and Instagram posts: “Israeli researchers have launched three clinical trials using the anti-inflammatory properties of CBD as a potential treatment for COVID-19 … Last week, InnoCan Pharma announced a partnership with the University of Tel Aviv to inculcate CBD medicine through exosomes … The unconventional method will use exosomes as “targeting missiles” as they can uniquely target COVID-19 damaged cell organs Researchers believe that the anti-inflammatory properties of CBD will repair damaged cells through a synergistic effect. “
Given the FDA’s recent focus on cannabis products and the alleged increase in the report of adverse events related to CBD and delta-8 products, it is likely that the FDA will continue to review product pages and social media sites related to cannabis products and will issue warning letters accordingly. Therefore, it is important for your company to review all marketing and promotional materials, including those found on social media, to ensure that you do not make unintended claims about your product. It will also be important for your company to understand and be prepared for any safety initiatives or regulations that the FDA may establish regarding these products.
The content of this article is intended to provide a general guide to the subject. Special advice should be sought on your specific circumstances.
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